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ADVANCED PATIENT MONITOR
Model PM-2000TM · ADVANCED INSTRUMENTATIONS, INC. · DI B510PM2000TM1
CBQ — Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500
CBR — Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1700
CBS — Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1620
CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase · Class II · 21 CFR 868.1400
CCL — Analyzer, Gas, Oxygen, Gaseous-Phase · Class II · 21 CFR 868.1720
DQA — Oximeter · Class II · 21 CFR 870.2700
DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) · Class II · 21 CFR 870.2300
DSA — Cable, Transducer And Electrode, Patient, (Including Connector) · Class II · 21 CFR 870.2900
DSI — Detector And Alarm, Arrhythmia · Class II · 21 CFR 870.1025
DSK — Computer, Blood-Pressure · Class II · 21 CFR 870.1110
DXN — System, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130
FLL — Continuous Measurement Thermometer · Class II · 21 CFR 880.2910
MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025
MLD — Monitor, St Segment With Alarm · Class II · 21 CFR 870.1025
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
12.02
2019-02
0
9.83
2019-03
0
11.51
2019-04
0
9.53
2019-05
0
8.55
2019-06
0
7.82
2019-07
0
9.62
2019-08
0
8.65
2019-09
0
11.19
2019-10
0
10.03
2019-11
0
10.95
2019-12
0
10.18
2020-01
0
9.32
2020-02
0
9.67
2020-03
0
10.37
2020-04
0
10.22
2020-05
0
7.59
2020-06
0
8.42
2020-07
0
7.64
2020-08
0
9.41
2020-09
0
9.88
2020-10
0
9.55
2020-11
0
16.7
2020-12
0
19.63
2021-01
0
14.9
2021-02
0
9.97
2021-03
0
12.6
2021-04
0
11.5
2021-05
0
9.19
2021-06
0
10.89
2021-07
0
10
2021-08
0
10.42
2021-09
0
9.46
2021-10
0
9.25
2021-11
0
10.45
2021-12
0
10.53
2022-01
0
9.64
2022-02
0
9.57
2022-03
0
11.19
2022-04
0
9.86
2022-05
0
11.87
2022-06
0
7.92
2022-07
0
7.24
2022-08
0
9.05
2022-09
0
9.37
2022-10
0
11.55
2022-11
0
8.81
2022-12
0
10.08
2023-01
0
7.91
2023-02
0
13.5
2023-03
0
15.33
2023-04
0
13.93
2023-05
0
14.98
2023-06
0
11.74
2023-07
0
16.82
2023-08
0
17.24
2023-09
0
18.53
2023-10
0
13.02
2023-11
0
16.24
2023-12
0
15.95
2024-01
0
15.91
2024-02
0
14.85
2024-03
0
16.69
2024-04
0
10.54
2024-05
0
12.81
2024-06
0
10.82
2024-07
0
13.58
2024-08
0
13.89
2024-09
0
15.51
2024-10
0
19.25
2024-11
0
14.56
2024-12
0
13.08
2025-01
0
15.6
2025-02
0
12.34
2025-03
0
16.08
2025-04
0
11.39
2025-05
0
11.97
2025-06
0
10.35
2025-07
0
13.31
2025-08
0
9.94
2025-09
0
8.88
2025-10
0
13.68
2025-11
0
10.42
2025-12
0
11.63
2026-01
0
10.67
2026-02
0
12.45
2026-03
0
12.33
2026-04
0
18.66
2026-05
0
15.53
2026-06
0
15.05
This device (reports/month)Average device in CBQ, CBR, CBS, CCK, CCL, DQA, DRT, DSA, DSI, DSK, DXN, FLL, MHX, MLD (reports/device/month)